BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 16400697 · Received February 17, 2023

    Report

    Report Number
    3005975494-2023-00026
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 18, 2023
    Report Date
    May 23, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KTI
    UDI-DI
    00821925043060
    PMA / PMN Number
    K163469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH INCORRECTLY REPORTED THE SITE REGISTRATION NUMBER. THE SITE REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN AT THIS TIME. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION (H6/H10), TO UPDATE H4, AND TO CORRECT E4 AS A MEDWATCH WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE (IFU): "ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE IN CASE THE PRIMARY INSTRUMENT MALFUNCTIONS" (PAGE 7). "IF YOU FEEL EXCESSIVE RESISTANCE WHILE OPERATING THE NEEDLE, DO NOT PUSH THE NEEDLE SLIDER FORCIBLY. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE" (PAGE 16 ). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED A MEDWATCH REPORT WITH AN EVENT/ PROBLEM REPORTED "DURING EBUS (ENDOBRONCHIAL ULTRASOUND ) PORTION OF PROCEDURE AFTER COLLECTING SAMPLE FROM STATION 10 L. THE NEEDLE WAS STUCK INSIDE SHEATH". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . THE EVENT REPORTED IN THIS MEDWATCH IS RELATED TO THE FOLLOWING REPORTS SUBMITTED UNDER PATIENT IDENTIFIER : (B)(6) (LOT KR151147) - EVENT DATE OF (B)(6) 2022. (B)(6) (UNKNOWN LOT) -DISPOSED BY THE CUSTOMER- NOT SAVED- EVENT DATE OF (B)(6) 2022. (B)(6) (LOT KR232986) - EVENT DATE OF (B)(6) 2022. (B)(6) (LOT KR232986) -UNKNOWN EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607687 SINGLE USE ASPIRATION NEEDLE VIZISHOT 2 FLEX KTI GYRUS ACMI, INC. NA-U403SX-4019 KR257487 00821925043060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown